E-Musb
E-musb MJU101, MODULE ASSEMBLY
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangyin Sinbon Electronics Co Ltd | Jiangyin | Jiangsu | Contract manufacturer | 13 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | QEM |
| Device type | Cerebral Oximeter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2700 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K213181 |
| Record published | 2022-05-13 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 90 % RH; Handling environment temperature 10 to 40 °C; Storage environment humidity 10 to 90 % RH; Storage environment temperature -20 to 60 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MJU101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Carescape B650 | GE Healthcare Finland OY | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.